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Identify federal legislation that control drug use and abuse.
Pure Food and Drug Act of 1906: set standards for drug labeling (everything had to be true); declare on label any identified dangerous or addicting substances (did not state if effective or safe); set standards for purity, potency, bioavailability, efficacy, and safety
Food, Drug, and Cosmetic Act of 1938: replaced the 1906 act; added the requirement of safety testing of drugs before marketing
Durham-Humphery Admendment 1952: distinguishes drugs that need or don't need a new prescription with refills
Kefauver-Harris Drug Amendment 1962: provisions for evaluation for testing method; tightened controlls on drug safety; establishement of effectiveness of new drugs
Controlled Substance Act 1970: 1) promotion of education and information on preventino and treatment of drug dependency, 2) strenthening of enforcement authority, 3) establish treatment facilities, 4) schedules for controlled substances
Differentiate among Schedule I, II, III, IV, and V medications.
Schedule I: high abuse potential; no accepted medical use
Schedule II: high abuse potential with medical use; written prescription only; no refills
Schedule III: medically accepted; may cause dependence; low physical, high psychological; written/oral prescription; 5 refills
Schedule IV: mild physical/psychological dependence; 5 refills
Schedule V: limited potential for dependence; written prescription or OTC
Describe the nursing responsibilites associated with the administrating of each schedule.
1) Account for all controlled drugs
2) Keep a special controlled-substance record for required information
3) Countersign all discarded or wasted medication
4) Ensure that documentation and drugs on hand match
5) Keep all controlled drugs in a locked storage area
6) Be certain that only authorized persons have access to the keys
Discuss how new drugs are tested for safety.
Phase I: small groups (20-100); 4-6 week trial; purpose: determine optimal dosage range and pharmacokinetics
Phase II: clients with disease, sevearl 100's; purpose: effective for diesase?, monitor SE
Phase III: large numbers (1000's), medical research centers; purpose: identify infrequent, rare adverse effects-double blind study; new drug application
Stage IV: post marketing survey; ongoing review; other uses; refine dose; drug interactions
Define orphan drugs.
no company would "adopt"; not profitable to develop; market too small or patent protection expired
Orphan Drug Act of 1983: research grants, protocol development by FDA, 7 year exclusive marketing rights (shortens approval process, because no one would want to develop the drug)
Discuss the role of the nurse in drug testing.
asking relevant questions about informed consent and risk to benefit ratio; awareness of initial indicators of change in the client; prediction of increased risk for adverse drug reactions; recruitment and assessment of study subjects; thorough understanding of protocol; validity and reliability of measurement instruments; ongoing teamwork; communication with health care providers
Define informed consent.
must be fully informed about all treatments to enable clients to make decisions about their health care; not coerced, alert; nurses teach about the medications
Identify ways to maintain confidentiality in drug administration.
respect privileged information; need to know; don't talk in public; don't discuss medications in front of others; always ID the client first
Purpose of medications.
1) Diagnosis of disease
2) Treatment of disease
3) Cure disease
4) Relief of symptoms
5) Prevention of disease
Chemical Name: drug's chemical compostition and molecular structure
Generic Name: common name used by any manufacturer
Official Name: chosen by FDA, often same as generic name
Trade Name: brand name; regestered name given by manufacturer
Units of measurment in metic system.
Metic to Household measurements.
Identify various routes for administering medications.
IM, IV, Subcut, Oral